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Effectiveness and Safety of Physical Exercises in the Improvement of the Sleep Quality. Regarding Rheumatoid Arthritis (SRA)

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Combined Training ( Strength + Aerobics)
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Rheumatoid Arthritis, Sleep Disorders, Polysomnography, Sleep Stages, Physical Exercise

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

• Women ages 35-65 years diagnosed with Rheumatoid Arthritis according with the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR)Criteria; Pittsburgh Sleep Quality Index ≥ 5; electrocardiogram test (ECG) at rest and at regular effort.

Exclusion Criteria:

  • Patients with joint restrictions due to disease.
  • Other rheumatoid-associated diseases (Fibromyalgia) with the exception of Osteoarthritis of low degree.
  • Those who are uncontrollably hypertense, diabetic, with thyroidopathy and cardiorespiratory diseases which stop them from practicing exercises.
  • Class II obesity (IMC ≥ 35 Kg/m2).
  • Cognitive deficits.
  • Depression.
  • Patients not following the study rules such as exercise hours and / or time for the proposed program.
  • Current physical exercise practitioner.
  • Those undergoing medication treatment which would interfere sleep.
  • Night shift workers who disrespect regular working schedule.

Sites / Locations

  • Centro de Estudos em Psicobiologia e Exercício (CEPE) da Associação Fundo de Incentivo a Pesquisa (AFIP)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Combined Training Group

Control Group

Arm Description

Combined Training - (strength + aerobics). A combined training (CT)is performed, having aerobics exercises (AE)using a stationary bicycle and strength training in workout devices. The strength training (ST) will be performed by isotonic exercises recruiting the main muscle groups. They exercises are: Chest Press, Leg Press, Vertical Traction, Leg Extension and Abdominal Crunch.

The control group patients did not perform any intervention through physical exercises. They were oriented on Sleep Hygiene and were followed during the study. They were asked to come to the following visits (at weeks 8 and 16) and to 2 additional visits to get and then return the actigraph. During this period, they were followed through phone calls once a month and were asked for sleep hygiene and were reminded of their assessment dates.

Outcomes

Primary Outcome Measures

Improvement of sleep through a polysomnogram exam.
Evaluation of N3 stage of the sleep through a polysomnogram before and after 16 weeks of supervised exercises.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2013
Last Updated
August 31, 2016
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01919645
Brief Title
Effectiveness and Safety of Physical Exercises in the Improvement of the Sleep Quality. Regarding Rheumatoid Arthritis
Acronym
SRA
Official Title
Effectiveness and Safety of Physical Exercises in the Improvement of the Sleep Quality in Women With Rheumatoid Arthritis: A Randomized Clinical Trial Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Physical exercise programs are effective and safe for the improvement of the sleep efficiency in patients with Rheumatoid Arthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Rheumatoid Arthritis, Sleep Disorders, Polysomnography, Sleep Stages, Physical Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined Training Group
Arm Type
Experimental
Arm Description
Combined Training - (strength + aerobics). A combined training (CT)is performed, having aerobics exercises (AE)using a stationary bicycle and strength training in workout devices. The strength training (ST) will be performed by isotonic exercises recruiting the main muscle groups. They exercises are: Chest Press, Leg Press, Vertical Traction, Leg Extension and Abdominal Crunch.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The control group patients did not perform any intervention through physical exercises. They were oriented on Sleep Hygiene and were followed during the study. They were asked to come to the following visits (at weeks 8 and 16) and to 2 additional visits to get and then return the actigraph. During this period, they were followed through phone calls once a month and were asked for sleep hygiene and were reminded of their assessment dates.
Intervention Type
Other
Intervention Name(s)
Combined Training ( Strength + Aerobics)
Intervention Description
Strength training performed using workout devices and aerobic training performed using stationary bicycle.
Primary Outcome Measure Information:
Title
Improvement of sleep through a polysomnogram exam.
Description
Evaluation of N3 stage of the sleep through a polysomnogram before and after 16 weeks of supervised exercises.
Time Frame
at baseline and at end-week 16

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Women ages 35-65 years diagnosed with Rheumatoid Arthritis according with the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR)Criteria; Pittsburgh Sleep Quality Index ≥ 5; electrocardiogram test (ECG) at rest and at regular effort. Exclusion Criteria: Patients with joint restrictions due to disease. Other rheumatoid-associated diseases (Fibromyalgia) with the exception of Osteoarthritis of low degree. Those who are uncontrollably hypertense, diabetic, with thyroidopathy and cardiorespiratory diseases which stop them from practicing exercises. Class II obesity (IMC ≥ 35 Kg/m2). Cognitive deficits. Depression. Patients not following the study rules such as exercise hours and / or time for the proposed program. Current physical exercise practitioner. Those undergoing medication treatment which would interfere sleep. Night shift workers who disrespect regular working schedule.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea H Kayo, PHD student
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Estudos em Psicobiologia e Exercício (CEPE) da Associação Fundo de Incentivo a Pesquisa (AFIP)
City
Sao Paulo
ZIP/Postal Code
04026-001
Country
Brazil

12. IPD Sharing Statement

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Effectiveness and Safety of Physical Exercises in the Improvement of the Sleep Quality. Regarding Rheumatoid Arthritis

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